BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1220513 · Received October 27, 2008

    Report

    Report Number
    1022556-2008-00617
    Event Type
    Other
    Date Received
    October 27, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 29, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1196-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVALUATION AND ANALYSIS. THIS REPORT IS BELOW THE THRESHOLD OF THE FDA'S REQUIREMENTS FOR MANDATORY REPORTING OF ADVERSE EVENTS INVOLVING MEDICAL DEVICES AS THERE IS NO EVIDENCE THAT USE OF THE PRODUCT RESULTED IN SERIOUS ADVERSE HEALTH CONSEQUENCES. INSTEAD, OUR INVESTIGATION HAS DETERMINED THAT THE PATIENT EXPERIENCED TEMPORARY OR MEDICALLY REVERSIBLE ADVERSE HEALTH CONSEQUENCES. ACCORDINGLY, THIS MDR IS BEING SUBMITTED AS A VOLUNTARY AND PROACTIVE MEASURE BY THE MANUFACTURER TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    THE CONSUMER CLAIMED HIS WIFE USED THE PRODUCT ON TWO OCCASIONS CAUSING BURNS RESULTING IN LESIONS/MARKS, WHICH HAVE NOT HEALED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 3A6Z5

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK